New regulatory program aims to expand patient access to innovative digital health devices while gathering real-world evidence to support future healthcare decisions
Silver Spring, Maryland, 27 July 2026 – The U.S. Food and Drug Administration has selected Dexcom as the first participant in its Technology Enabled Meaningful Patient Outcomes, or TEMPO, Digital Health Devices Pilot. The program is designed to improve patient access to innovative digital health technologies while allowing manufacturers to collect real-world performance data under FDA oversight.
The TEMPO pilot focuses on digital health devices that support people living with chronic diseases. These technologies are expected to help patients monitor their health more effectively, improve communication with healthcare providers, and encourage earlier intervention before health conditions become more serious.
Dexcom was selected for its Glucose Health Program, a digital health solution designed to help identify and manage prediabetes and Type 2 diabetes. The FDA will continue evaluating the technology during the pilot to understand how it performs in real-world healthcare settings while maintaining patient safety.
Unlike traditional approval processes, the TEMPO pilot allows selected companies to introduce certain digital health technologies under carefully monitored conditions while collecting real-world evidence. This approach gives regulators valuable information on how these devices perform in everyday clinical use without compromising patient protection.
The program also supports the Centers for Medicare and Medicaid Services ACCESS Model, which focuses on improving care for people with chronic conditions through technology-enabled healthcare solutions. By combining regulatory oversight with real-world clinical data, the initiative aims to make digital health innovations available to patients more quickly while ensuring they remain safe and effective.
Healthcare experts believe digital health devices are becoming increasingly important as chronic diseases continue to affect millions of people. Wearable sensors, remote monitoring platforms, and connected healthcare applications can help patients track their health at home, reduce unnecessary hospital visits, and provide doctors with continuous health information instead of occasional clinic measurements.
The FDA has indicated that additional manufacturers may be selected for the TEMPO pilot in the coming months. As more companies join the program, regulators expect to gain broader insights into how digital health technologies can improve patient outcomes across different medical conditions.
The launch of the TEMPO pilot marks another step toward integrating digital innovation into healthcare delivery. By encouraging responsible innovation while maintaining strong regulatory standards, the initiative has the potential to improve chronic disease management, support healthcare providers, and expand access to modern medical technologies for patients across the United States.